“Me llamo Paloma Cabeza Jiménez”: Macchiarini victim speaks out

Paloma was supposed to the second trachea transplant patient of Paolo Macchiarini's in Barcelona, in summer 2008. The scandal surgeon gave her a fake diagnosis of a lethal tracheal cancer which she never had, and also "accidentally" mislocated her stent during a enforced bronchoscopy. All to coerce his patient to agree to a trachea transpalnt. Paloma had a lucky escape, twice. She namely also encountered Thorsten Walles.

Paloma was supposed to the second trachea transplant patient of Paolo Macchiarini‘s at the Hospital Clinic Barcelona, in summer 2008. The first patient was as we all know, Claudia Castillo, operated on 12 June 2008, her alleged success story let both Macchiarini and his UK partner Martin Birchall build their stellar careers in regenerative medicine.

Paloma met Claudia in the Macchiarini’s waiting room in Hospital Clinic, the two women kept in touch afterwards. Eventually, Claudia saved her hospital acquaintance by warning her what really was happening to her transplant: that the piece of dead trachea Macchiarini installed as replacement for her left bronchus became necrotic, that she was suffering while Macchiarini manipulated medical data and sent false results to the journal Lancet, where her case was published in November 2008 as Macchiarini et al 2008. As Paloma told me, Claudia is now doing well, after several years of suffering and many interventions which Macchiarini performed on her between 2010 and 2013 in the Careggi hospital in Florence and in another hospital in Rome. Paloma and Claudia met again on Christmas 2012, Claudia was still positive. Yet by mid-2013, Claudia’s rotting bronchus graft was “filled with loose nylon threads from biodegradable prostheses that did not degrade well”, which blocked the airflow to her lung in addition to the constant inflammation and infection there.

To save her health, Claudia returned to Spain and to Hospital Clinic and eventually demanded they remove the rotting bronchial graft together with her left lung. Which was done in 2016, the constant sickness and suffering were over. The previously published 5-year follow-up Lancet paper Gonfiotti et al 2014 is simply a bunch of Macchiarini’s phony make-believe inventions, as even the Hospital Clinic determined, but the elite medical journal prefers it this way. That phony Lancet paper even has image manipulations.

PubPeer evidence of data manipulation in 5year follow-up paper about Claudia Castillo. Quote: “An image appears in a 2010 and a 2014 paper. In each case it depicts a scanning EM view of a surface of a decellularised trachea.Of interest:(a) Only one of these images is for a re-bodged trachea transplanted into a patient; the other is used experimentally.(b) One of these images is for the inside, the other for the outside of these by now cell-free tracheas.”

Paloma shared her medical records with me, which collaborate her story above (and its translation below). Yes, Macchiarini gave her on 7 July 2008 a fake diagnosis of “Neoplasia maligna de traquea”, of a lethal tracheal cancer which she never had. Miraculously, the deadly cancer went away without a trace just 6 days later, the new diagnosis became and stayed tracheal stenosis. Macchiarini also “accidentally” mislocated Paloma’s bronchial stent during a bronchoscopy which he forced upon his sedated patient against her wishes. The displaced stent blocked Paloma’s airways and caused her left lung to collapse, in danger of becoming necrotic. All that was conveniently needed to turn Paloma into a suitable trachea transplant candidate. Everything was in place, Macchiarini even announced that a doctor from London was on his way to collect her tissue samples and grow a trachea in his lab. This can only be the newly appointed UCL professor Martin Birchall, who previously made a trachea for Claudia, in a veterinary lab at his previous workplace in Bristol.

Paloma had the strength to refuse the therapy Macchiarini tried to impose on her. Others were not so lucky. We already know of a middle aged woman from Argentina whom Macchiarini operated illegally in October 2009 at the neighbouring Hospital Dexeus, where he transferred his work in summer 2009 after Hospital Clinic forbade him any further trachea transplants. That patient is apparently not alive anymore, only her initials are known: DD. Her memory exists only in hidden traces of Macchiarini’s own records and on my site. Just as with Claudia, that trachea transplant served to educate Macchiarini’s German acolyte and student from Hannover, Philipp Jungebluth. German courts recently saw no issues of his watching illegal or unethical experiments on foreign patients, but they saw my reporting about those as libellous damage to his surgery career in Germany.

Apparently, there was another Macchiarini victim whom Paloma saw with her own eyes, and who then disappeared without a trace. As Paloma recalled, that woman of a Middle Eastern origin was assigned to the private clinic BarnaClínic and operated at the collaborating Hospital Clínic of Barcelona in the fall of 2008. She died either around Christmas 2008 or in the first trimester of 2009. Paloma told me what she witnessed:

“She was middle-aged (45-50 years approximately). She arrived with her husband and two large suitcases. She wore a veil and I think she was from the Arab Emirates. I learned from the nurses on the night shift that she spent weeks in the ICU (intensive care unit) in grave condition and with great suffering. Macchiarini used her as a guinea pig and tested it with her.This woman came to the hospital walking on her own feet, so it was very serious when she arrived at the hospital.Her husband noticed the deception and demanded a plane to take his wife back home, but she was so broken that she could not leave and died there”.

Antoni Castells, Medical Director of the Hospital Clínic of Barcelona, told me that he couldn’t find any death records matching this description. But then again, Macchiarini is known to have been keeping very sloppy records of his patients. Especially of the ones who died quickly.

After her disastrous experience with Macchiarini, Paloma contacted in September 2009 another star surgeon of regenerative medicine, a German. Guess whom. It was Macchiarini’s former surgery trainee from the time at Hannover Medical School, Thorsten Walles. Who developed together with his wife Heike Walles a method of growing trachea grafts from pig intestine, celebrated at that time in books and news, and over which I was sued for bringing the forgotten back to memory. This was Thorsten Walles’ email from 17 September 2009:

“The concept of our work is to generate human tissues with a vascular network. The network is generated from the patient’s own cells. The cells are obtained from a biopsy (2×2 cm) of the thigh which can be done – if the patient wants it – in local anesthesia. Currently we are able to generate transplants of 15×4 cm size. So far, we have successfully treated 2 patients with tracheal/tracheo-esophageal defects. In theory, we might be able to offer you some treatment.
However, on July 15th a new pharmaceutical law came into effect in Germany. Unfortunately, this new law requires an official manufacturing licence for our transplants. We already applied for this manufacturing licence at the governmental authorities. Currently, I can not tell you when this licence will be issued to us. As long as a patient (like you) is not in life-threatening condition that only can be solved by a bioartificial transplant, we are not allowed to proceed with our therapy, until we have received the manufacturing licence. But we are working for that”.

Ten days later, Walles was slightly more positive to be able to help soon:

“Your wanted to know the differences between the techniques of Paolo Macchiarini and me:
Prof. Macchiairni uses tracheal tissue from an organ donor which is retrieved at time of organ explantation. He then removes the cells of this person and puts some cells of the patient that he wants to operate on this cell-free tissue.
We do pretty much the same, but we do not need tracheal tissue from a human donor. We take a jejunal segment from pig and remove all animal cells. In contrast to Prof. Macchiarini we can generate blood vessels in our transplants that can be connected to the reciepient’s blood supply at time of implantation.
The difference of our 2 approaches has two effects:
1. Prof. Macchiarinis transplants are porbably more durable/strong at time of implantation. But they will soften due to the lack off tissue vescularization.
2. Our transplants are softer. Therefore we (currently) can only treat tracheal and bronchial lesions where at least some cartilage tissue is healthy. Otherwise we would have to stabilze our transplants with a stent or some other device. We know from experience in patients that our transplants survive and that they mature and become more durable within the first few weeks following transplantation. At that time it would be possible to remove the stabilizing stent that was needed at the beginning. However, so far we did not implant our transplants together with stents and I definetely want to avoid a combination of stents and bioartificial transplants as stents cause problems in the airways – as you know”.

The story of those Walles patients is here, they were operated without any ethics approvals or previous safety tests. The Fraunhofer Institute in Stuttgart, where Heike Walles made the grafts, was even proud of skipping animal experimenting and going straight into patients. One of the things Walleses sued me for, was for suggesting Macchiarini ever made any bioartificial scaffolds at all. That court trial I resolved with a settlement, where I admitted that Macchiarini had no scientific contribution to the papers with Walles where he is corresponding author. Both Walleses are presently under miscodnuct investigation by the University of Würzburg.

I was much less lucky when Macchiarini’s right hand mann Jungebluth sued me, twice. I was sentenced in two farcical trials where court cheated and twisted facts and English language for the benefit of the smiling plaintiff, and imposed two hefty fine on top. To teach an immigrant like myself to respect doctors, as the judge made clear.

In Sweden, Macchiarini’s manslaughter charges were dropped on outrageously inappropriate expert advice. In USA, his business partners are being sued for his trachea transplants, but he himself is safe. In Italy, Macchiarini even has political support, which sure helped him win in court against charges of extortion. Not all legal issues are gloomy. Paloma already won a court case in 2012, where the Health Ministry was sentenced to compensate her for medical malpractice she suffered. Maybe Paloma will sue Macchiarini next. Rumours go, he is back working as surgeon in Rome, but his official residency is still at his villa in Barcelona.

Paloma Cabeza Jiminez in 2006, before she met the bad doctors.

Now the translation of Paloma’s own story:

My name is Paloma Cabeza Jiménez

I am 43 years old and I live in Alicante although I was born in Madrid (Spain)

When only 10 years old, I had a domestic accident with a caustic soda.

At that time (1986) tracheal lesions were not handled with good success or judgement.

My primary lesion was only two centimeters long and because of poor medical decisions and few resources … those two centimeters degenerated into a lesion that covered the entire length of the trachea, which forced me to place a “T”-type silicone prosthesis called Montgomery in 1992 (the summer I turned 18 years old).

After years of multiple replacements of Mongomerys to avoid bacteria colonization, they realized that those same manipulations in the operating room (every 3-6 months) were favoring and causing the appearance of new bacteria by contamination, and in addition to this fact, the manipulation itself destroyed the natural regeneration of tracheal mucosa.

Likewise, the repeated manipulations with rigid fibrobronchoscopy and aspirations … partially damaged my left main bronchus, which left me with a stable stenosis with a diameter between 6-7mm. An opening size which is compatible with a normal quality of life if you do not intend to be a professional athlete.

In 2006, tired of fighting recurrent respiratory infections, I went to get advice from a pulmonologist in Barcelona and I had the bad luck of falling into the hands of an unprofessional specialist who affirmed with firm conviction that the cause of my infections was the slight stenosis of my left bronchus. My desire to be a mother and to have a healthy foetus pregnancy … clouded my reasoning and I ignored my internal voice, intuition, which warns you of the imminent dangers. Misguided also by my unsuspecting husband at that time, I agreed to be put in the operating room to dilate the left main bronchus.

That could not come out worse! They destroyed the cartilaginous structure of the BPI (left main bronchus) and I was left with the need for a bronchial silicone prosthesis throughout entire length (5cm) called DUMON.

From 2006 to 2011, I lived a true hell of spare parts due to constant migrations of Dumon; which caused causing weekly suffocation crisis, mucosal clogging and many more respiratory infections, more serious than before. So I gambled for the possibility of removing the tracheal Montgomery stent to overcome the infection, and was left instead with two prostheses: TRAQUEAL AND BRONCHIAL.

My despair was so great that in 2008 I began to follow the progress in trachea at the international level and I learned that there is a certain Paolo Macchiarini working on a new technique of trachea transplantation, without immunosuppressants against rejection and that promised to be the salvation for all the patients who suffer from this distressing ailment. Without hesitation, I contacted him by mail, since it was endorsed by a “prestigious Spanish hospital” which would soon operate on our King for a lung injury.

Dr. Macchiarini’s secretary gave me an appointment almost immediately and we had face-to-face consultation in June 2008.

Macchiarini told me about the infinite benefits of his technique and ultimately got me to buy into that intervention. My feeling at that time was bad because I just returned from another medical negligence where they also painted everything very facial and beautiful and for me this was a sign. Once again, the character of my husband and his candor led us into a serious mess. Macchiarini said that it was essential to go through an operating room to assess my case and that none of my reports from Madrid or Alicante were any good, not even the recent ones of the bronchial lesion in Barcelona (Hospital Bellvitge), or the recent radiological tests (TAC) ) … that contributed and gave insight into my case. He managed to convince my husband and by this also me, but I begged and begged asking: I told Macchiarini that it was very difficult to fix the Dumon in the exact place of the bronchus so as not to cause injury or movement … I did not give consent for its manipulation or its removal. I told him that I would prefer the bronchus left with the Dumon and to use flexible bronchoscopy to avoid further injuries, and with new radiological tests of high resolution. He gave me his word and I believed him blindly thanks to that friendly and kind-hearted smile that he usually puts when he wants something from you.

Once in the operating room he did what he wanted and how he wanted. Not only did he remove the Dumon, but he also did a biopsy without my consent and performed an unnecessary LASER surgery to cause burn injuries that would help him justify what he wanted to do weeks later: HIS SECOND TRANSPLANTATION OF TRACHEA INTO MY LEFT BRONCHUS. The same, and even in the same place, which Claudia Castillo had done weeks ago. Patient with whom (luckily for me) I coincided in three different hospital admissions. Claudia was suffering a lot because of the physical situation she was living with at that time and because of her job and economic situation, since she had two children and the girl was only 5-6 years old. I helped her with money to spend the summer as good as possible and we exchanged phone numbers to tell each other how we both progressed, since we were going to be operated on the same thing.

My summer was horrible because of the granulomas the laser surgery caused me, plus the Dumon that was placed badly, and the week-long infections later due to badly drained secretions, and the bleeding from the intervention, plus the collapse of the left lung that was caused by the Dumon moving into the tracheal Carina, which became THAT SUMMER IN A HELL IN OPERATING ROOMS WITH PROSTHESIS, CORTICOIDES, ANTIBIOTICS ….

Luckily for me, I moved on little by little from that situation and had the immense fortune to get a compassionate call from Claudia, who after 3 months of her transplant could already confirm that everything had gone wrong, that she did not allow me to undergo the surgical intervention, and that I ran out of the hospital.

She told me that Macchiarini was hiding data and even manipulating reports and results he sent to the LANCET magazine. I was admitted to the hospital Clinic, and Claudia was discharged home with symptoms of suffocation, and large amounts of corticosteroids to withstand it plus two overlapping antibiotics to prevent the worsening of infection, since her graft was necrotic due to lack of blood flow. After digesting such news and trying to have a rest that night, I faced Macchiarini the next morning in the solitude of my room when he arrived on a routine visit.

At no time did he admit that Claudia was doing badly and told me that those were my things, and that I would have misunderstood Claudia. That everything was a matter of doubt as he claimed and that I was confused by the typical fear that arises just before facing something new (like when you’re going to marry).

That cynicism left me speechless, completely perplexed. He took advantage of my silence to tell me: “Oh, I have the solution, I will be right back.” An hour later he showed up with the hospital psychiatrist (I think he was the head of the Psychiatry Department of the Hospital Clinic Barcelona), whom he had previously instructed to try to manipulate me and convince me to accept the surgery, since the next morning everything was arranged in the operating room to remove tissue from the cartilage of the nose and stem cells from the bone marrow. In addition, the doctor’s colleague was on his way, who, according to him, came from London to take the samples and prepare a trachea there, that would be like a clone of mine and place it in the left main bronchus. He came to say that I would suffer less than Claudia because in these three months the technique had improved.

My refusal was firm. He had decided during the night. I had recalled loose phrases that when put together made me understand that I was faced with a dangerous man, who to top it off brought a psychiatrist who constantly phrased things without logical sense like wanting to convince me of an urgency that DIDN’T NOT EXIST. That was the trigger for me to tell the psychiatrist that what he was trying to do with me was shameful, and that I would never forgive him that attempt to manipulate me.

Macchiarini became CHOLERIC, he threatened me screaming like a madman. He told me that he would kick me out of the hospital even without letting me recover and that he would make a thousand calls to make sure no trachea specialist would be attending to me, that he would speak ill of me so that I would suffer medical reprisals in the future, and that he swore to me that one day I would return to the hospital begging him for help and he would deny it to me. I will never forget his eyes of crazy madman. He left my room giving such a slam that soon after the other doctors of the thoracic department came to know what had happened and to my surprise everyone knew and that CLAUDIA CASTILLO WAS DOING BADLY AND THEY STILL APPROVED MY SURGERY!!!!!

That same day I asked to be discharged and months later (when I learned that Macchiarini stopped working at the hospital) with the trauma of not having found trachea specialists in Spain, I begged the second surgeon on board, Dr. Gimferrer, to attend to me and he did so, because he explained that he had suffered a lot working with Macchiarini and had nothing to do with him and his actions. Sadly and years later I learned that there was another team of trachea specialists in a city called Valencia and much closer to the city of Alicante, which was where I lived.

Years later I learned that Macchiarini was let go by the Hospital Clinic Barcelona.He was kindly invited not to renew the contract. This fact has followed the ruin of many families and the death of several innocents. For example, a patient of 52 years at the DEXEUS clinic in Barcelona would not have died if the team that worked with him in the Hospital Clinic Barcelona had reported him for MALPRACTICE, for lack of ethics and for several other things that come to mind. TODAY THERE ARE AT LEAST 8 PEOPLE TO WHOM I PUT FACE AND NAME.

I ignorantly thought and blindly believed that the Hospital Clinic Barcelona had thrown out Dr. Paolo Macchiarini, suspending his medical license. I thought that they had denounced him for his bad behavior, but it was not so and the silence of them all … in the years 2008-2009 caused the agony of months of suffering and the death of innocent and misled people by the medicine that is practiced today and that we have a moral duty to change.

It is not right that the word of a doctor can become the WORD OF GOD, and it is even less understandable that in 2018 the corporatism or medical camaraderie in some Latin countries such as Spain prioritized collegial favors over public health.

This psychopathic surgeon had the nerve to report that I had malignant tracheal cancer (when MY DIAGNOSIS was always the same: benign tracheal stenosis after mechanical inflammation) in order to justify his procedures and the worst thing is that his accomplices did not stop him. I had to stop him! A patient who in theory would not have to know anything about medicine! But I had the luck and the misfortune to accumulate previous painful experiences with a lot of medical background and I could understand every contradiction …. that saved me with that phone call from Claudia, who somehow returned the favour for which I had done her weeks before.

In 2013 I managed to get rid of the Dumon bronchial prosthesis thanks to a treatment with the growth hormone or Somatropin, which regenerates at the cartilage and is injected subcutaneously, as it is done with insulin.

Currently, I am being controlled by specialists in the city of Valencia and I am in the process of tracheal recovery. I have not lost my left bronchus, nor have I lost my left lung (as it was intended in 2011 at that damn Hospital Clinic Barcelona for not wanting to give me other alternatives and pretending to take the shortest and easiest way for them and thus to get rid of me, of someone who knew the whole truth and could cause them problems) nor have I lost my life because of medical egocentrism taken to the highest level. If I have to define my experience during 7 years in the Hospital Clinic of Barcelona: CORPORATIVISM AND SHOWING OFF 100% ABOVE EVERYTHING ELSE.

In August 2016 (at 42 years of age) and almost 8 months pregnant, after an incessant struggle … .. I moved back to Alicante and a month and a half later my son Mario was born. A healthy and precious child who today is 20 months old and has come to my life as the most important miracle of all, after I lived through these 34 years of hardship and forced but willful struggle.

My son is my greatest motivation and true medicine. I give thanks to life for having compensated me in this way and put my knowledge and experience in the hands of those who need it because I know first hand the loneliness that we patients with tracheal stenosis and tracheostoma have because for us there are no associations to inform and help us. Everything we learn, we do it by paying a very high price and many times the price of learning is our own life.

To all the families of the victims of Macchiarini and in general to all the victims of bad medical decisions, of proven negligence and of negligence which due to corruption was not proven, I send my utmost respect, affection, and in some way, my own history.

Wishing you the peace and tranquility that every human being needs to live, I say goodbye.

Paloma Cabeza Jiménez

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Horrible story. Lucky escape for Paloma and great betrayal by medicine and by legal system. Prison is the only right place for this guy. Thanks again to whistleblowers from KI who exposed Macciarini and all other people ( including Leonid) who helped to finish his activities.

Many thanks to Paloma for sharing her experiences and to Leonid for providing a forum where patients can tell their stories and be listened to.

A key problem here is the apparent ease in which vulnerable patients can be used as experimental subjects by unscrupulous clinicians who are more interested in furthering their careers than in the welfare of their patients.

Another problem in this particular case is that the transnational collaboration likely made it easier for the researchers involved in trachea transplant experiments to bamboozle the regulatory authorities in their respective countries.

So far, meaningful investigations into trachea transplant operations have only taken place in Sweden and Iceland. It is crucial that similar investigations are conducted in other countries where these operations have taken place, including Spain and the UK. As a first step, the institutions, hospitals, regulatory authorities, ethics committees and funding bodies that facilitated these activities need to acknowledge that mistakes were made. This has not yet happened. The next step would then be to investigate how the mistakes happened, and then introduce measures to reduce the chances of it happening again.

An important message that should be learned from the trachea transplant scandal is that unproven regenerative medicine therapies should not be tested on human patients without good evidence for safety and efficacy.

Trish Murray
Professor of Stem Cell Biology and Regenerative Medicine,
University of Liverpool, UK
previously a nurse on head and neck unit

Just to add that the Swedish investigation I refer to above is the investigation undertaken by the Karolinska University Hospital (report published 31/08/2016), which did an excellent job of identifying and discussing the key components of the Macchiarini scandal in Sweden. The recent report of the Karolinska Institute is not so excellent because while it calls for retractions of Macchiarini’s papers, which is most welcome, it also finds the whistleblowers who uncovered the scandal as either guilty or blameworthy of research misconduct, which is simply not credible.

Leonid, thank you for this incredible and compelling article and thank you Paloma for your sharing your story! I have never heard of such a travesty of ethical and humane medical care! Paloma’s story is heart wrenching and I wish the best for her and all that suffer from this type of disease. This is worst kind of psychopathic behavior in medicine imaginable.

Horrible story. So many Universities have protected this man and Karolinska Institutet destroys the Whistleblowers that exposed them. I am ashamed to work at the Karolinska and will leave this horrible place as soon as I can.

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